Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

Recruiting now

Conditions studied: Cerebral Hypoxia, Ischemic Stroke

In brief

The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.

Key facts

Study ID

NCT04971564

Run by

Fondation Ophtalmologique Adolphe de Rothschild

People needed

200

Starts

2024-03-19

Expected to finish

2026-06-22

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For cases, admitted within the first 36 hours of an acute neurological symptom related to :
• An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,
• A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,
• An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission >4.
• OR
• For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score.
• Express consent to participate in the study.
• Member or beneficiary of a social security.

You may not qualify if…

• Pre-existing functional and/or cognitive disability
• Patient under legal protection.
• Pregnant or breastfeeding woman.
• Patient with secondary haemorrhagic transformation.
• Secondary exclusion criteria :
• Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy.
• Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.).
• TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.
• Excluded patients will be replaced.

Where it is running

• Hôpital Fondation Adolphe de Rothschild — Paris, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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